LINEAR ALKYLBENZENE SULFONATE (LAS) - UNEP Chemicals

More documents

Recommendations

Info

OECD SIDS LINEAR ALKYLBENZENE SULFONATE (LAS) effects were seen on reproduction or embryonic development in either animal species. Method: (A) Rat studies The rats were divided into seven groups consisting of 25 males and 25 females after a five day acclimation period in the laboratory. The tallow alkyl ethoxy sulfate (55%)-LAS(45%) mixture (TAE3S/LAS) was mixed into the ground commercial feed at levels of 0.1, 0.5 or 1.0% and fed to two generations of male and female rats continuously or only to females during each period of organogenesis (days 6-15) of pregnancy. A control group was fed the commercial feed with no additive. The parent animals body weights were recorded weekly for the first eight weeks in each generation and afterwards recorded only at each mating phase. Once sexually mature, five rats of each sex per group were sacrificed for histology during each generation. The remaining rats were mated on a oneto-one basis three successive times during each generation. The first two pregnancies (F1a, 1b, 2a and 2b) in each generation were allowed to proceed to natural births. These pups were counted and inspected for abnormalities at birth. The third pregnancies in each generation (F1c and F2c) were used for teratology purposes. At weaning all pups except the F1b litters, which became the second generation parents, were discarded. Animals for the second generation were selected on the same basis as previously described for the first generation. During the third pregnancies of both generations (F1c and F2c), one-half of each group of females was sacrificed on day 13 of gestation. A laparotomy was performed and the number of corpora lutea of pregnancy and the number of implantation and resorption sites were observed and recorded. On day 21 of gestation, the remaining dams were examined in a similar manner. One-third of the fetuses in each of the third litters were examined for skeletal development and defects. The others were examined for soft tissue defects. During the teratology period, tissues were collected from five parent females of each group and from five parent males of the control and continuously treated groups. The heart, liver, kidneys and gonads were weighed, blood was taken for routine hemograms, and tissues were set in 10% formalin, paraffin-sectioned and stained with haemotoxylin-eosin for histopathy. (B) Rabbit study Five groups of 25 sexually mature does were distributed on the based on body weights and litter mates. The does were artificially inseminated with 0.25 mL of undiluted semen, collected from sperm-tested untreated males. Ovulation was induced by a 1 mg/kg injection of PLH immediately prior to insemination. The day of insemination was considered day 0 of gestation. The TAE3S/LAS mixture was administered by gavage from day 2 through day 16 of gestation at daily doses of 50, 100, or 300 mg/kg of body weight. Distilled water was the vehicle and each doe received 2 mL of solution per kg of bodyweight. For the control groups, one received no treatment and the other received a treatment with water. In order to monitor the dose level, the females were weighed every three days. The dams were sacrificed on day 28 of gestation and the number of corpora lutea, resorptions and live or dead fetuses were observed and recorded. The fetuses were removed and treated and examined for abnormalities. GLP: Yes [ ] No [ ] ? [X] Test substance: A mixture of 55% tallow alkyl ethoxylate sulfate (TAE3S) and 45% LAS (assumed Procter and Gamble products) Remarks: The authors indicate that rats received up to 6000 times the estimated “worstcase” human exposure without causing any deleterious effects on the development or variability of the embryo or fetus. Rabbits also received UNEP PUBLICATIONS 298
OECD SIDS LINEAR ALKYLBENZENE SULFONATE (LAS) doses many times the “worst-case” human dose without causing significant effects. Reference: Nolen, G.A., Klusman, L.W., Patrick, L.F. and Geil, R.G. 1975. Teratology studies of a mixture of tallow alkyl ethoxylate and linear alkylbenzene sulfonate in rats and rabbits. Toxicology. 4:231-243. Reliability: 2 Valid with restrictions (l) Species/strain: Rat: CD Sex: Female [X]; Male [ ]; Male/Female [ ]; No data [ ] Administration: Dermal Exposure period: days 2 through 15 of gestation Frequency of treatment:daily Doses: 0.03, 0.3, or 3% on the shaved skin as 0.5 ml aqueous solution. Control group: Yes [X]; No [ ]; No data [ ]; Concurrent no treatment [X]; Concurrent vehicle [ ]; Historical [ ] NOAEL Maternal: 0.3% (6 mg/kg bw d) NOAEL teratogenicity: 3% (60 mg/kg bw d) Results: Maternal toxicity: At the high dose, local irritation was observed resulting in a slightly lower body weight gain and hypersensitivity (i.e., animals were increasingly irritable). Teratogenicity: No differences were observed among the dose groups and the control group with respect to number of litters, viable young, litter weight, foetal weight, embryonic deaths, implantations, corpora lutea, or pre- and post implantation embryonic loss. The incidences of major malformations, minor visceral or skeletal anomalies, and skeletal variants were not different between controls and dose groups even at maternal by toxic doses. Method: The dosage volume was 0.5 mL which was applied to an area of skin (4x4 cm) from which the fur was removed. The nominal doses were 0.6, 6.0, and 60 mg/kg bw d. GLP: Yes [ ] No [X] ? [ ] Test substance: Japan LAS; average alkyl chain length (based on LAS SIDS Consortium Survey, 2002) = C11.7. Reference: Palmer, A.K., Readshaw, M.A. and Neuff, A.M. 1975b. Assessment of the teratogenic potential of surfactants (Part III) – Dermal application of LAS and soap. Toxicology 4:171-181. Reliability: 2 Valid with restrictions (m) Species/strain: Rat/Wistar Sex: Female [X]; Male [ ]; Male/Female [ ]; No data [ ] Administration: Dermal Duration of the test: sacrifice at day 21 of gestation Exposure period: 21 days (days 0 through 21 of gestation) Frequency of treatment:Daily Doses: 0.05, 0.1, and 0.5% (0.1, 2 and 10 mg/kg bw d) or 1.0, 5.0, and 20% (20, 100, and 400 mg/kg bw d) Control group: Yes [X]; No [ ]; No data [ ]; Concurrent no treatment [X]; Concurrent vehicle [ ]; Historical [ ] NOAEL Maternal: 1% (20 mg/kg bw d) NOAEL teratogenicity: 20% (400 mg/kg bw d) Results: Maternal toxicity: The dams treated with 20% and 5% showed inhibition of body weight gain and local skin effects. UNEP PUBLICATIONS 299
Page 1 and 2:
OECD SIDS LINEAR ALKYLBENZENE SULFO
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
Page 205 and 206:
Page 207 and 208:
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 215 and 216:
Page 217 and 218:
Page 219 and 220:
Page 221 and 222:
Page 223 and 224:
Page 225 and 226:
Page 227 and 228:
Page 229 and 230:
Page 231 and 232:
Page 233 and 234:
Page 235 and 236:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243 and 244:
Page 245 and 246:
Page 247 and 248: OECD SIDS LINEAR ALKYLBENZENE SULFO
Page 297: OECD SIDS LINEAR ALKYLBENZENE SULFO
Page 349 and 350:
Page 351 and 352:
Page 353 and 354:
Page 355 and 356:
Page 357:
show all

LINEAR ALKYLBENZENE SULFONATE (LAS) - UNEP Chemicals

Create successful ePaper yourself

Delete template?

Save as template?